Mylan subsidiary gets approval for HIV generic under PEPFAR

By Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved a generic drug for HIV made by a subsidiary of Mylan under a program that supplies drugs to people living with HIV in developing countries, Mylan said Tuesday.

The FDA approved Matrix Labs’ atazanavir sulfate capsules in the 150-mg and 300-mg strengths. The drug is a generic version of Bristol-Myers Squibb’s Reyataz. The FDA approved the generic version under the President’s Emergency Program for AIDS Relief, or PEPFAR, which allows Mylan’s product to be distributed in certain developing countries, but not in the United States.

“This approval is yet another step in improving access to quality, affordable treatment for people living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said. “Atazanavir has a distinct resistance profile compared with other protease inhibitors and is an important addition to the product portfolio being made available to patients in developing countries.”